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New drug combo tested for tough bile duct cancers

NCT ID NCT05712356

Disease control Sponsor: Lisata Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called LSTA1 added to standard treatment for people with advanced bile duct or gallbladder cancer. The goal was to see if the combination is safe and works better than standard treatment alone. The trial was stopped early, and results are not yet available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

May 2023

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥ 3 months * At least one measurable lesion as assessed by RECIST 1.1 * Adequate organ and marrow function * Adequate contraception * Patients with either of the following: * Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization). Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible. * Pathologically confirmed metastatic or unresectable cholangiocarcinoma or GBC with progression of disease after first-line chemotherapy and immunotherapy. Exclusion Criteria: * Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: * Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment * Active infection (viral, fungal, or bacterial) requiring systemic therapy * Known active hepatitis B virus, hepatitis C virus, or HIV infection * Active tuberculosis as defined per local guidance * History of allogeneic tissue/solid organ transplant * Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast * Pregnant or breastfeeding * Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization * History or clinical evidence of symptomatic central nervous system (CNS) metastases

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Conditions

The condition(s) this trial relates to.

bile duct cancer bile duct neoplasm cholangiocarcinoma Disease Progression extrahepatic bile duct carcinoma gallbladder cancer gallbladder carcinoma gallbladder neoplasm intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bile duct cancer Cholangiocarcinoma Extrahepatic cholangiocarcinoma Gall bladder cancer Gall bladder carcinoma Gallbladder cancer Gallbladder carcinoma Intrahepatic cholangiocarcinoma

Contacts and locations

Locations

  • Alliance for Multispecialty Research

    Merriam, Kansas, 66204, United States

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219, United States

  • FirstHealth of the Carolinas, Inc.

    Pinehurst, North Carolina, 28374, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Northwell Health - Zuckerberg Cancer Center

    Lake Success, New York, 11042, United States

  • Norton Cancer Institute, Audubon

    Louisville, Kentucky, 40217, United States

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303, United States

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.